Cell therapy weekly: US FDA program to accelerate COVID-19 therapies
Also this week: Avectas obtains patent for cell engineering platform and clinical trial starts to tackle COVID-19.
The news highlights:
The US FDA (MD, USA) has announced an ‘all-hands-on-deck' approach to tackling the COVID-19 pandemic. With the new Coronavirus Treatment Acceleration Program, the agency plans to cut red-tape and expedite therapies, enabling them to reach critically ill patients as swiftly as possible, while still maintaining safety standards.
"As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies. We are grateful to the men and women of the FDA who have been working in concert with industry and other parts of the Department of Health and Human Services (MD, USA) to support potential coronavirus treatments for weeks now," commented Alex Azar, Department of Health and Human Services Secretary.
Avectas (Dublin, Ireland) has announced the approval of its US patent claim (No. 10612042) on the Solupore® delivery platform. Solupore is a cell engineering platform designed to deliver proteins and nucleic acids across plasma membranes and has been created specifically with therapeutic products in mind. In February 2020, Avectas announced a collaboration agreement with the Centre for Commercialization of Regenerative Medicine (CCRM; ON, CA) to advance the transition of Solupore to the clinic.
"Our patented cell engineering platform leverages a new mechanism to permeabilize the cell membrane and to enable the delivery of therapeutic molecules into the cell, enabling the production of functionally fitter cells to recognize and attack cancers," stated Michael Maguire, Chief Executive Officer of Avectas. "This granted patent is an important component in our IP portfolio, protecting value in our cell engineering platform. We look forward to continuing the development of Solupore to address the tremendous need for a new cell engineering technology for next-generation cell therapies."
Orbsen Therapeutics (Galway, Ireland) has announced the start of a Phase IIa clinical trial involving the company’s stromal cell immunotherapy product, ORBCEL. The trial has been approved by the Medical Health Regulatory Agency (MHRA; London, UK) and will investigate the effect of the therapy on acute respiratory distress syndrome, a condition that results in nearly 90% of COVID-19-related deaths.
"The successful completion of ORBCEL's Phase I clinical trial, intended to assess ORBCEL safety in patients, confirms our belief in the potential of Orbsen's proprietary stromal cell immunotherapy technologies," explained Larry Couture, CEO of Orbsen Therapeutics. "We believe ORBCEL will prove a valuable addition to the arsenal of therapies to combat the effects of COVID-19."
For more weekly cell therapy news, read previous editions of the cell therapy weekly.
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